A trial to see if an MRI biomarker can decide treatment after chemoradiotherapy for people with rectal cancer (TRIGGER trial)

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This trial is for people who are having chemotherapy with radiotherapy (chemoradiotherapy) before surgery for rectal (bowel) cancer.

More about this trial

Chemoradiotherapy before surgery is a treatment for rectal cancer. The aim of this treatment is to shrink the cancer making surgery more likely to be successful.

There can be differences in how well the chemoradiotherapy works. Doctors know this from looking at bowel tissue taken out after surgery. In some people the chemoradiotherapy completely gets rid of the cancer (a good response) and in other people the cancer stays the same or even grows (a poor response).

In this trial doctors want to look at a smarter way of reading the results of an MRI scan after chemoradiotherapy. They are looking at a biomarker called the mrTRG (MRI tumour regression grade). They want to see if it is possible to choose treatment based on the mrTRG results.

The feasibility trial is now completed and the team found that it was safe and acceptable to patients. They now are doing a larger phase 3 trial.

The aims of the trial are to see if mrTRG can

tell how well the chemoradiotherapy has worked

help to make decisions about treatment

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

Blood and tissue samplesThe researchers will ask you if a sample of your rectal cancer taken when you were diagnosed can sent to a central laboratory at the Royal Marsden Hospital in London. You’ll also have some extra blood tests.

They use the cancer sample to find out more about the type of bowel cancer you have. The blood samples are for other bowel cancer research and won’t be used in your own treatment.

Quality of lifeThe doctors would like to know more about your quality of life at the start of your treatment. You complete 3 short questionnaires that have questions about how your bowels work and your general health.

The doctors will also ask to collect information about your health after you have taken part in the trial.

You do not have to do step 1 if you don’t want to, you can still take part in step 2 of the trial. Or you can choose to only do step 1 of this trial.

Step 2This starts after you finish your chemoradiotherapy.

This part of the trial is randomised. In the last 2 weeks of your chemoradiotherapy you will be put into 1 of 2 treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

One group has current standard treatment (the control group)

The other group will be split depending on whether people had a good or a poor response to chemoradiotherapy (the intervention group)

You have a 2 out of 3 chance of being in the intervention group.

Control groupAfter completing your chemoradiotherapy you have

an MRI scan after 4 to 6 weeks

surgery after 6 to 8 weeks

4 to 8 weeks after your surgery you have up to 6 months of chemotherapy (called adjuvant chemotherapy).

You have a combination of chemotherapy drugs called CapOx or FolFox or you may just have one drug. This is either capecitabine or fluorouracil (5 FU).

Intervention groupEveryone in this group has an MRI scan 4 to 6 weeks after finishing their chemoradiotherapy. Using the mrTRG (MRI tumour regression grade) the doctors decide if you have had a good or a poor response to the treatment.

Intervention group- good responseYou have chemotherapy for 6 months. You start 6 to 8 weeks after finishing your chemoradiotherapy.

You have a combination of chemotherapy drugs called CapOx or FolFox or you may just have one drug. This is either capecitabine or fluorouracil (5 FU).

You then have follow up appointments

every 3 months for the first 2 years

every 6 months until 5 years after your finished the chemoradiotherapy

At most of these visits you have blood tests, an MRI scan and a flexible sigmoidoscopy. At some visits you have a CT scan as well as the MRI scan and a colonoscopy instead of the sigmoidoscopy.

If any of these tests show your cancer is no longer shrinking or it has started to re grow you have surgery.

Intervention group – poor responseYou have 3 months of chemotherapy. You start 6 to 8 weeks after finishing your chemoradiotherapy.

You have a combination of chemotherapy drugs called CapOx or FolFox or you may just have one drug. This is either capecitabine or fluorouracil (5 FU).

After 3 months you have an MRI scan. What happens next depends on how well the treatment has worked.

A poor response, you have about 3 to 4 weeks to recover from the chemotherapy. Then you have surgery and 4 to 8 weeks later another 3 months of chemotherapy.

Agood response, you discuss with your doctor whether to have surgery or not. You have another 3 months of chemotherapy if you choose not to have surgery.

You then have follow up appointments

every 3 months for the first 2 years

every 6 months until 5 years after your finished the chemoradiotherapy

At most of these visits you have blood tests, an MRI scan and a flexible sigmoidoscopy. At some visits you have a CT scan as well as the MRI scan and a colonoscopy instead of the sigmoidoscopy.

You have surgery if any of these tests show your cancer is no longer shrinking or it has started to re grow.

Blood and tissue samplesThe doctors will ask if a sample of your cancer can sent to a central laboratory at the Royal Marsden Hospital in London if you have surgery. They use this for research to understand more about bowel cancer and how your can influence how successful treatment is.

They ask everyone to have extra blood tests. They use these for the same research as above. Where possible they take the extra blood samples at the same time as any routine blood tests you have.

You do not have to give these samples if you don’t want to. You can still take part in the trial.

Hospital visits

How often you need to go to hospital for your chemotherapy treatment will depend on what chemotherapy drugs you have.

You have FolFox, oxaliplatin and fluorouracil (5 FU) as a drip into the vein. Capecitabine is a tablet.

How often you see the doctors after treatment depends on which group you are in

control group – you see the doctors every year for 3 years

intervention group – if you have surgery you see the doctors every year for 3 years

intervention group- no surgery – you have follow up as described in Trial design

At some of these follow up appointments they will ask you to complete a quality of life questionnaire. These include questions about your health and about how your bowels are working.

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